Themobile health Screening To Prevent Strokes(mSToPS) trial investigated whether or not it is possible to identify a high-risk cohort suitable for targeted detection for asymptomatic atrial fibrillation.

Participants in the study were engaged in a mobile-health-technology-enabled monitoring program to document previously undiagnosed AF and provide clinical evidence of an outcomes benefit associated with early detection.1

Results2

Clinical Implications2

Study Design1

2,659 individuals were randomized to either immediate monitoring with an iRhythm Zio patch, or delayed monitoring to be initiated 4 months after consent.

Participants were asked to wear the patch for 2 weeks, on 2 different occasions, at the beginning and the end of a 4 month active monitoring period.

Participants were:

Identified through claims analysis

Randomized to receive immediate or delayed monitoring

Received routine care during unmonitored periods

In addition, for each monitored participant, up to 2 observational control participants (matched for age, sex, and CHA2DS2VASc score) were identified from the pool of eligible members who did not receive an invitation.

The primary endpoint was the incidence of newly diagnosed AF, either clinically or through monitoring in the immediate cohort (defined by ≥30 seconds of atrial fibrillation or flutter), compared with clinical monitoring alone in the delayed cohort.

"This device was chosen because of its demonstrated utility, high degree of patient compliance, and sensitivity in detecting arrhythmias."

Beyond the focus on improved health, another important aspect of the mSToPS trial is that it provides great value in determining the best techniques for developing large, pragmatic, real-world, and relatively inexpensive clinical trials made possible through the use of an array of digital medicine technologies.1